Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy

Hepatic Malignant Neoplasm Primary Non-Resectable Clinical Trial

Official title:

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03266042
• Other study ID #: PHP-M-REG01
• Status: Recruiting
• Start date: January 14, 2016
• Est. completion date: February 2020

Study information

• Verified date: September 2018
• Source: Delcath Systems Inc.
• Contact: Leslie Callahan, BSN, MS
• Phone: 212-489-2100
• Email: lcallahan[@]delcath.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Description:

Post Marketing study:

The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.

This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.

Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.

The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.

2. Have provided written informed consent according to institutional and regulatory guidelines

Related Conditions & MeSH terms

• Hepatic Malignant Neoplasm Primary Non-Resectable
• Liver Neoplasms
• Neoplasms

Locations

Country	Name	City	State
United Kingdom	Southampton University Hospitals and University of Southampton	Southampton
United Kingdom	Spire Southampton Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Delcath Systems Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).	Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge	Post-procedure (up to 30 days after CS-PHP)
Secondary	Percentage of treatment with CHEMOSAT each patient receives	The percentage of treatments with CHEMOSAT each patient receives based on primary tumor	From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
Secondary	Evaluation of Best Overall Response	Evaluation of patient best overall response (partial response or complete response, when applicable)	from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
Secondary	Evaluation of resource utilization	Percentage of days spent in ICU, step-down area	From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
Secondary	Evaluate time to treatment failure	Time of first CHEMOSAT treatment to time of treatment failure	time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]